31. August 2018
Combined micro- and nanosystems are appealing for pulmonary protein delivery, fulfilling the specific physiological requirements for efficient outcomes in-vivo. However, fabrication of protein formulations may impose stresses perturbing protein conformational stability and, hence, biological activity. Herein, a protein, insulin (INS), was nanoencapsulated inside chitosan nanoparticles (CS NPs) by ionic gelation. By spray drying, the resultant protein-loaded NPs were further encapsulated with a...
29. August 2016
A string of new guidance documents have made it clear that data integrity (DI) remains high on the agenda of regulatory authorities around the world and this has become a global issue. DI in the context of pharma manufacturing has led to a rising number of regulatory enforcement actions citing failures in the recording and review of manufacturing data. In some cases violations have led to written warning letters and even bans on imports from some manufacturing facilities. The extent of draft...